Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix

Gingival Recession Clinical Trial

— EmdoDerm  

Official title:

Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05799859
• Other study ID #: EmdoDerm
• Status: Completed
• Phase: N/A
• Start date: January 9, 2017
• Est. completion date: September 22, 2022

Study information

• Verified date: March 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The clinical trial studies patients with gingival recession defects (receding gums).

The goal of the study is to test whether the additional use of enamel matrix derivatives (EMD), combined with the use of a coronally advance flap (CAF) and a CM (collagen matrix), shows a better outcome compared to a comparison group. The comparison group comprises patients receiving treatment with CAF and CM without the use of EMD.

Description:

The study aims to evaluate the influence of the additional use of EMD in treatment of gingival recession defects using a coronally advance flap (CAF) and a CM (collagen matrix) by means of digital and clinical assessment methods. The reference group comprises patients receiving treatment with CAF and CM without the application of EMD.

In this prospective, randomized, controlled study, recession height and area, width and thickness of keratinized gingiva, pocket probing depth, and the clinical attachment level were measured at baseline and followed-up for one year.

15 patients with 24 gingival recession defects (Recession Type 1 after Cairo/Miller Class I or II) were recruited and were randomly assigned into the two treatment groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 22, 2022
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

Inclusion Criteria:

• Signed Informed Consent

• able to achieve good oral hygiene (full mouth plaque score < 20 %, full mouth bleeding score < 20%),

• patients presenting with at least one gingival recession defect

Exclusion Criteria:

• general contraindications to dental surgery under local anaesthesia (e.g., severe systemic diseases, tumours, severe cardiovascular diseases, uncontrolled diabetes mellitus);

• ongoing or previous chemotherapy, radiotherapy, or bisphosphonate therapy;

• self-reported heavy smokers (more than 10 cigarettes/day);

• pregnancy and nursing mothers;

• disorders or treatments that impair wound healing;

• long-term treatment with high-dose steroids or anticoagulants;

• bone metabolism disorders;

• infections or vascular disorders in the region to be treated;

• known hypersensitivity to porcine collagen;

• patients with severe peripheral artery disease or autoimmune diseases;

• extruded or malpositioned teeth.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Device:
• Use of coronally advanced flap (CAF) and collagen matrix (CM)

• Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival recession height	Gingival recession height in millimeters, measured as the distance from cementoenamel junction to gingival margin	12 months postoperatively
Secondary	Width of keratinized tissue (WKT)	Width of keratinized tissue in millimeters, .as distance between gingival margin and muco-gingival junction	12 months postoperatively
Secondary	pocket probing depth (PPD)	Pocket probing depth in millimeters, measured as the distance from gingival margin to bottom of gingival sulcus	12 months postoperatively
Secondary	Clinical attachment loss (CAL)	Clinical attachment loss in millimeters	12 months postoperatively